Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)

Myocardial Infarction Clinical Trial

Official title:

Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02512978
• Other study ID #: Z15110700400000
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: June 2019

Study information

• Verified date: July 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Wen-Yao Wang, MD,PhD Candidate
• Phone: 8618810488381
• Email: wwypumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

Description:

The primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for AMI is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 75, male or non-pregnant female;

2. Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);

3. With presence of hypothyroid status (i.e., TSH >7.0 mIU/L and (or) fT3 <1.79 pg/mL);

4. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;

2. Symptoms of severe heart failure (Killip Class III and above);

3. Severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;

4. Impaired liver function before surgery: Serum GPT > 120U/L;

5. Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;

6. Those taking medicine which can affect the test of thyroid function;

7. Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;

8. Those having prior myocardial infarction;

9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Related Conditions & MeSH terms

• Hypothyroidism
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Levothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.

Locations

Country	Name	City	State
China	Fuwai Cardiovascular Hospital	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Peking University Third Hospital, The Luhe Teaching Hospital of the Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (12)

Bai MF, Gao CY, Yang CK, Wang XP, Liu J, Qi DT, Zhang Y, Hao PY, Li MW. Effects of thyroid dysfunction on the severity of coronary artery lesions and its prognosis. J Cardiol. 2014 Dec;64(6):496-500. doi: 10.1016/j.jjcc.2014.03.009. Epub 2014 Jun 17. — View Citation

Cakar M, Demirbas S, Demirkol S, Karaman M, Balta S, Unlu M. Chicken or egg? Which one is first? Myocardial infarction or low thyroid hormones? Intern Med. 2013;52(5):645. Epub 2013 Mar 1. — View Citation

Ceremuzynski L, Górecki A, Czerwosz L, Chamiec T, Bartoszewicz Z, Herbaczynska-Cedro K. Low serum triiodothyronine in acute myocardial infarction indicates major heart injury. Kardiol Pol. 2004 May;60(5):468-80; discussion 473-4. English, Polish. — View Citation

Chen YF, Kobayashi S, Chen J, Redetzke RA, Said S, Liang Q, Gerdes AM. Short term triiodo-L-thyronine treatment inhibits cardiac myocyte apoptosis in border area after myocardial infarction in rats. J Mol Cell Cardiol. 2008 Jan;44(1):180-7. Epub 2007 Oct — View Citation

Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a ret — View Citation

Mourouzis I, Forini F, Pantos C, Iervasi G. Thyroid hormone and cardiac disease: from basic concepts to clinical application. J Thyroid Res. 2011;2011:958626. doi: 10.4061/2011/958626. Epub 2011 Jun 19. — View Citation

Mourouzis I, Giagourta I, Galanopoulos G, Mantzouratou P, Kostakou E, Kokkinos AD, Tentolouris N, Pantos C. Thyroid hormone improves the mechanical performance of the post-infarcted diabetic myocardium: a response associated with up-regulation of Akt/mTOR — View Citation

Mourouzis I, Mantzouratou P, Galanopoulos G, Kostakou E, Roukounakis N, Kokkinos AD, Cokkinos DV, Pantos C. Dose-dependent effects of thyroid hormone on post-ischemic cardiac performance: potential involvement of Akt and ERK signalings. Mol Cell Biochem. — View Citation

Pingitore A, Chen Y, Gerdes AM, Iervasi G. Acute myocardial infarction and thyroid function: new pathophysiological and therapeutic perspectives. Ann Med. 2012 Dec;44(8):745-57. doi: 10.3109/07853890.2011.573501. Epub 2011 May 13. Review. — View Citation

Tang YD, Kuzman JA, Said S, Anderson BE, Wang X, Gerdes AM. Low thyroid function leads to cardiac atrophy with chamber dilatation, impaired myocardial blood flow, loss of arterioles, and severe systolic dysfunction. Circulation. 2005 Nov 15;112(20):3122-3 — View Citation

Wang WY, Tang YD, Yang M, Cui C, Mu M, Qian J, Yang YJ. Free triiodothyronine level indicates the degree of myocardial injury in patients with acute ST-elevation myocardial infarction. Chin Med J (Engl). 2013 Oct;126(20):3926-9. — View Citation

Zhang B, Peng W, Wang C, Li W, Xu Y. A low fT3 level as a prognostic marker in patients with acute myocardial infarctions. Intern Med. 2012;51(21):3009-15. Epub 2012 Nov 1. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging		within 6 months of patient enrolled
Secondary	Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging	Patterns of myocardial perfusion/metabolism were classified as normal, mismatch, mild-moderate match and severe match	Within 6 months of patient enrolled
Secondary	The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)		Within 6 months of patient enrolled
Secondary	Major adverse cardiac and cerebrovascular events	The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident.	within 12 months of patient enrolled
Secondary	Death by any cause		Within 12 months of patient enrolled

External Links

•   heart attack
•   hypothyroidism
•   levothyroxine